Comparison of Expressed (pumped out) Breast Milk and 10% Dextrose when given orally in reducing intensity of pain in newborns before painful procedures (like heel prick) done as a part of newborn care.
Not Applicable
- Registration Number
- CTRI/2021/06/034053
- Lead Sponsor
- Dr Dasari Sandhya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Term Healthy Neonates(Babies who have completed 37 weeks gestational age) requiring heel prick procedure for monitoring hypoglycemia like Low birth weight babies(LBW),Infants of Diabetic mothers(IDM) done routinely as a part of newborn care protocol
Exclusion Criteria
1) Neonates who require resuscitation at birth, 2) Neonates on Life support like CPAP/oxygen/ Ventilator 3) Neonates with congenital anomalies pertaining to head and face - cleft lip and palate 4) Sick neonates-sepsis, neonatal seizure 5) Preterm babies( <37 completed weeks)and post term babies( >42 completed weeks) 6) Neonates whose parents refuse to consent for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the effect of Expressed breast milk (EBM) vs 10% Dextrose over intensity of pain in term neonates using NIPS scale (Neonatal Infant Pain Scale)Timepoint: NIPS (Neonatal infant pain scale) score would be assigned to the neonate before the heel prick procedure and at 30 secs, 2 mins and 4 mins after the procedure and documented by observer 2.
- Secondary Outcome Measures
Name Time Method 1.To assess and compare the duration of cry in term neonates following the use of EBM and 10% Dextrose <br/ ><br>2.To compare the changes in physiological variables like Heart Rate, SpO2 between both groups after the painful procedure; following administration of EBM or 10% Dextrose. <br/ ><br>Timepoint: The observer 1 will document the duration of the cry and record changes in heart rate and SPO2 at 30 secs, 2 mins and 4 mins after the procedure